[Federal Register Volume 63, Number 250 (Wednesday, December 30, 1998)]
[Notices]
[Pages 71920-71924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34291]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-850; FRL-6050-1]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by the docket control number PF-850, must 
be received on or before January 29, 1999.

ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: The product manager listed in the 
table below:

[[Page 71921]]



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                                   Office location/
        Product Manager            telephone number          Address
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Treva C. Alston...............  Rm. 707B, CM #2, 703-   1921 Jefferson
                                 308-8373, e-            Davis Hwy,
                                 mail:alston.treva@epa  Arlington, VA
                                 mail.epa.gov.
Hoyt Jamerson.................  Rm. 268, CM #2, 703-    Do.
                                 308-9368, e-mail:
                                 jamerson.hoyt@epamail
                                 .epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain data or information regarding the elements set forth in section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-850] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [PF-850] and appropriate petition 
number. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: December 17, 1998.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

1. Huntsman Corporation of Houston, Texas

PP 8E4992

    EPA has received a pesticide petition (PP 8E4992) from Huntsman 
Corporation of Houston, Texas, proposing pursuant to section 408(d) of 
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to amend 
40 CFR part 180 to establish an exemption from the requirement of a 
tolerance for propylene carbonate and butylene carbonate (4-(methyl and 
ethyl)-(1,3-dioxolan-2-one)) when used in accordance with good 
agricultural practice as an inert ingredient in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest. EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

     Analytical method. An analytical residue method utilizing 
chromatography with a flame-ionization detector is available for 
enforcement purposes.

B. Toxicological Profile

    1. Acute toxicity. Acute toxicity studies include an acute oral rat 
study on propylene carbonate with an LD50 of 29,100 
milligrams/kilogram of body weight (mg/kg/bwt), an acute oral mouse 
study on propylene carbonate with an LD50 of 20,700 mg/kg/
bwt, an acute dermal toxicity study in the rat with an LD50 
>5,000 mg/kg, acute inhalation studies in the rat, dog, and guinea pig 
with an LD50 values >3,000 mg/L (airborne concentration), a 
primary eye irritation study with rabbits indicating that propylene 
carbonate is a slight eye irritant, a primary dermal irritation study 
in the rabbit showing propylene carbonate to be a non-irritant and 
dermal sensitization studies in humans showing propylene carbonate is 
not a skin sensitizer.
    2. Genotoxicity. The mutagenic potential of propylene carbonate has 
been evaluated in several studies covering a variety of endpoints. It 
is concluded that propylene carbonate is not mutagenic. Mutagenic 
studies with propylene carbonate include gene mutation assays in 
bacterial and mammalian cells; in vitro, and in vivo chromosomal 
aberration assays; and an in vivo DNA repairs assay in mammalian cells. 
All studies were negative for genotoxicity.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study with rats given oral gavage doses of up to 5,000 mg/kg/
day from days 6 through 15 of gestation resulted in a no observed 
adversed effect level (NOAEL) for maternal toxicity of 3,000 mg/kg/day 
based upon bwt reduction at the highest doses. There was no evidence of 
developmental toxicity or any malformations in fetuses at any of the 
dose levels, including the highest dose of 5,000 mg/kg/day.
    4. Subchronic toxicity. A 28 day oral subchronic toxicity study was 
conducted with propylene carbonate in rats at rates up to 5,000 mg/kg/
day. Treatment related increased ovary weights, and testes weights were 
observed at the highest dose and increased ovary weights were observed 
at the two highest dose levels of 3,000 and 5,000 mg/kg/day. The NOAEL 
was 1,000 mg/kg/day.
    i. A 90 day oral subchronic toxicity study was conducted with 
propylene carbonate in rats at rates up to 5,000 mg/kg/day. There was 
reduced body weight and food consumption at the high dose level. Male 
kidneys also had reduced weight at the high dose group and there

[[Page 71922]]

were some minor blood chemistry changes. The authors concluded that 
there were no apparent toxicological effects from the consumption of 
propylene carbonate at rates up to 5,000 mg/kg/day over 90 days.
    ii. A 14 week whole-body exposure inhalation toxicity study was 
conducted with propylene carbonate in rats at rates up to 1,000 mg/
m3. In this study, neurotoxic motor responses were also 
monitored. The authors concluded that there were no toxicological 
effects from the consumption of propylene carbonate at rates up to 
1,000 mg/m3 except minimal eye irritation.
    5. Chronic toxicity. A 24 month chronic oral toxicity study in mice 
was conducted with propylene carbonate by application twice per week to 
clipped areas of the back. There were no tumors and no skin irritation 
as a result of treatment propylene carbonate in this study.

C. Aggregate Exposure

    The following is a description of the likelihood of exposure to 
propylene and butylene carbonate from various routes.
    1. Dietary exposure. Propylene and butylene carbonate are cleared 
as an indirect food additive under 21 CFR 175.105 for use as an 
indirect food additive in packaging. This clearance obtains from the 
use of propylene, and butylene carbonate in packaging glue and other 
indirect food additive uses. Little or no migration into the food 
substance is expected from these uses according to the information 
included in 21 CFR.
    Propylene and butylene carbonate are not cleared for any 
applications to growing crops or to crops after harvest at this time, 
but following granting of this exemption, this will be the primary 
source of dietary exposure.
    2. Non-dietary exposure. Propylene and butylene carbonate are 
solvents used in surface cleaners, degreasers, dyes, fibers, plastics, 
batteries, and as a gelling agent for clays. There would be additional 
exposure from theses routes.

D. Cumulative Effects

    Propylene and butylene carbonate are members of a class of 
compounds with structures containing the carbonate moiety. The closest 
related compound, ethylene carbonate, is used in similar, non-
agricultural applications, but does not have any uses which would 
result in agricultural exposure or dietary exposure.

E. Safety Determination

    1. U.S. population. Owing to the very high reference dose, it is 
not reasonable to assume any acute or chronic health effects to the U. 
S. population. Propylene and butylene carbonate are reduced-risk inerts 
which will reduce exposure to more toxic inert solvents.
    2. Infants and children. There is a complete data base for 
propylene, and butylene carbonate which includes pre- and post-natal 
developmental toxicity data. The toxicological effects of propylene and 
butylene carbonate on rodents are well understood.
    In a developmental toxicity study in rats, all reproductive 
parameters investigated showed no treatment-related effects except 
slightly retarded growth rate. Maternal effects were seen at 5,000 mg/
kg/day without developmental effects. The NOAEL for reproductive 
effects in offspring is 5,000 mg/kg/day.

F. International Tolerances

    A maximum residue level has not been set for propylene and butylene 
carbonate by the Codex Alimentariosu Commission.

2. Interregional Research Project Number 4 (IR-4)

 PP 0E3909, 2E4052, 2E4092, 3E4162, and 9E5049

    EPA has received a request regarding pesticide petitions (PP 
0E3909, 2E4052, 2E4092, 3E4162) from IR-4, New Jersey Agricultural 
Experiment Station, Rutgers University, New Brunswick, New Jersey 08903 
to remove the time limitations on the established tolerances in 40 CFR 
part 180.412 for the the herbicide sethoxydim (2-1-(ethoxyimino)butyl-
5-2-(ethylthio)propyl-3-hydoxy-2-cyclohexen-1-one) and its metabolites 
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide)) 
in or on asparagus at 4.0 parts per milllion (ppm), carrot at 1.0 ppm, 
cranberry at 2.0 ppm, peppermint, and spearmint tops at 30 ppm. EPA has 
also received a petition (PP 9E5049) from IR-4 proposing pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing a tolerance for 
residues of sethoxydim and its metabolites containing the 2-cyclohexen-
1-one moiety (calculated as the herbicide) in or on the raw 
agricultural commodity horseradish at 4 ppm. EPA has determined that 
the petitions contain data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the permanent tolerances. Additional data 
may be needed before EPA rules on the petitions. This notice includes a 
summary of the petitions prepared by BASF Corporation, Agricultural 
Products, P.O. Box 13528, Research Triangle Park, NC 27709.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residues in 
plants and animals is adequately understood for the purposes of 
registration.
    2. Analytical method. Analytical methods for detecting levels of 
sethoxydim and its metabolites in or on food with a limit of detection 
that allows monitoring of food with residues at or above the levels set 
in these tolerances were submitted to EPA. The proposed analytical 
method involves extraction, partition, and clean-up. Samples are then 
analyzed by gas chromatography with sulfur-specific flame photometric 
detection. The limit of quantitation (LOQ) is 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity. Based on the available acute toxicity data, 
sethoxydim does not pose any acute dietary risks. A summary of the 
acute toxicity studies follows.
    i. Acute oral toxicity--Rat. Toxicity Category III; 
LD50=3125 milligrams/kilogram(mg/kg) (male), 2676 mg/kg 
(female).
    ii. Acute dermal toxicity--Rat. Toxicity Category III; 
LD50 >5,000 mg/kg (male and female).
    iii. Acute inhalation toxicity-- Rat. Toxicity Category III; 
LC50 (4-hour)=6.03 mg/L (male), 6.28 mg/L (female).
    iv. Primary eye irritation--Rabbit. Toxicity Category IV; no 
irritation.
    v. Primary dermal irritation--Rabbit. Toxicity Category IV; no 
irritation.
    vi. Dermal sensitization--Guinea pig. Waived because no 
sensitization was seen in guinea pigs dosed with the end-use product 
Poast (18% a.i.).
    2. Genotoxicity. Ames assays were negative for gene mutation in 
Salmonella typhimurium strains TA98, TA100, TA1535, and TA 1537, with 
and without metabolic activity.
    A Chinese hamster bone marrow cytogenetic assay was negative for 
structural chromosomal aberrations at doses up to 5,000 mg/kg in 
Chinese hamster bone marrow cells in vivo.
    Recombinant assays and forward mutations tests in Bacillus 
subtilis, Escherichia coli, and S. typhimurium were all negative for 
genotoxic effects at concentrations of greater than or equal to 100%.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rats fed dosages of 0, 50, 180, 650, and 1,000 mg/kg/
day with a maternal

[[Page 71923]]

no-observed adverse effect level (NOAEL) of 180 mg/kg/day and a 
maternal lowest obsereved adverse effect level (LOAEL) of 650 mg/kg/day 
(irregular gait, decreased activity, excessive salivation, and 
anogenital staining); and a developmental NOAEL of 180 mg/kg/day, and a 
developmental LOAEL of 650 mg/kg/day (21 to 22% decrease in fetal 
weights, filamentous tail, and lack of tail due to the absence of 
sacraland/or caudal vertebrae, and delayed ossification in the hyoids, 
vertebral centrum and/or transverse processes, sternebrae and/or 
metatarsals, and pubes).
    A developmental toxicity study in rabbits fed doses of 0, 80, 160, 
320, and 400 mg/kg/day with a maternal NOAEL of 320 mg/kg/day and a 
maternal LOAEL of 400 mg/kg/day (37% reduction in body weight gain 
without significant differences in group mean body weights and 
decreased food consumption during dosing); and a developmental NOAEL 
greater than 400 mg/kg/day highest dose tested (HDT).
    A 2-generation reproduction study with rats fed diets containing 0, 
150, 600, and 3,000 ppm (approximately 0, 7.5, 30, and 150 mg/kg/day) 
with no reproductive effects observed under the conditions of the 
study.
    4. Subchronic toxicity A 21 day dermal study in rabbits with a 
NOAEL of >1,000 mg/kg/day (limit dose). The only dose-related finding 
was slight epidermal hyperplasia at the dosing site in nearly all males 
and females dosed at 1,000 mg/kg/day. According to BASF this was 
probably an adaptive response.
    5. Chronic toxicity. A summary of the chronic toxicity studies 
follows.
    A 1-year feeding study with dogs fed diets containing 0, 8.86/9.41, 
17.5/19.9, and 110/129 mg/kg/day (males/females) with a NOAEL of 8.86/
9.41 mg/kg/day (males/females) based on equivocal anemia in male dogs 
at the 17.5-mg/kg/day dose level.
    A 2-year chronic feeding/carcinogenicity study with mice fed diets 
containing 0, 40, 120, 360, and 1,080 ppm (equivalent to 0, 6, 18, 54, 
and 162 mg/kg/day) with a systemic NOAEL of 120 ppm (18 mg/kg/day) 
based on non-neoplastic liver lesions in male mice at the 360-ppm (54 
mg/kg/day) dose level. There were no carcinogenic effects observed 
under the conditions of the study. The maximum tolerated dose (MTD) was 
not achieved in female mice.
    A 2-year chronic feeding/carcinogenic study with rats fed diets 
containing 0, 2, 6, and 18 mg/kg/day with a systemic NOAEL greater than 
or equal to 18 mg/kg/day HDT. There were no carcinogenic effects 
observed under the conditions of the study. This study was reviewed 
under current guidelines and was found to be unacceptable because the 
doses used were insufficient to induce a toxic response and an MTD was 
not achieved.
    A second chronic feeding/carcinogenic study with rats fed diets 
containing 0, 360, and 1,080 ppm (equivalent to 18.2/23.0, and 55.9/
71.8 mg/kg/day (males/females). The dose levels were too low to elicit 
a toxic response in the test animals and failed to achieve an MTD or 
define a LOAEL. Slight decreases in body weight in rats at the 1,080 
ppm dose level, although not biologically significant, support a free-
standing NOAEL of 1,080 ppm (55.9/71.8 mg/kg/day (males/females)). 
There were no carcinogenic effects observed under the conditions of the 
study.
    6. Animal metabolism. In a rat metabolism study, excretion was 
extremely rapid and tissue accumulation was negligible.
    7. Metabolite toxicology. As a condition to registration, BASF had 
been asked to submit additional toxicology studies for the hydroxy 
metabolites of sethoxydim. EPA agreed with BASF's recommendation to use 
the most abundant metabolite, 5-OH-MSO2, as surrogate for all 
metabolites. Based on these data, it was concluded that the 
toxicological potency of the plant hydroxymetabolites is likely to be 
equal to or less than that of the parent compound. The tolerance 
expression for sethoxydim measures sethoxydim and its metabolites 
containing the 2-cyclohexen-1-one moiety, measured as parent. Hence, 
the hydroxymetabolites are figured into all tolerance calculations.
    8. Endocrine disruption. No specific tests have been performed with 
sethoxydim to determine whether the chemical may have an effect in 
humans that is similar to an effect produced by naturally-occurring 
estrogen or other endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. For purposes of assessing the potential 
dietary exposure, BASF has estimated aggregate exposure based on the 
Theoretical Maximum Residue Contribution (TMRC) from existing and 
pending tolerances for sethoxydim. (The TMRC is a ``worst case'' 
estimate of dietary exposure since it is assumed that 100% of all crops 
for which tolerances are established are treated and that pesticide 
residues are at the tolerance levels.) The TMRC from existing 
tolerances for the overall U.S. population is estimated at 
approximately 44% of the RfD. BASF estimates indicate that dietary 
exposure will not exceed the RfD for any population subgroup for which 
EPA has data. This exposure assessment relies on very conservative 
assumptions 100% of crops will contain sethoxydim residues and those 
residues would be at the level of the tolerance which results in an 
over estimate of human exposure.
    2. Other exposure. Other potential sources of exposure of the 
general population to residues of pesticides are residues in drinking 
water and exposure from non-occupational sources. Based on the 
available studies submitted to EPA for assessment of environmental 
risk, BASF does not anticipate exposure to residues of sethoxydim in 
drinking water. There is no established Maximum Concentration Level 
(MCL) for residues of sethoxydim in drinking water under the Safe 
Drinking Water Act (SDWA).
    BASF has not estimated non-occupational exposure for sethoxydim. 
Sethoxydim is labeled for use by homeowners on and around the following 
use sites: flowers, evergreens, shrubs, trees, fruits, vegetables, 
ornamental groundcovers, and bedding plants. Hence, the potential for 
non-occupational exposure to the general population exists. However, 
these use sites do not appreciably increase exposure. Protective 
clothing requirements, including the use of gloves, adequately protect 
homeowners when applying the product. The product may only be applied 
through hose-end sprayers or tank sprayers as a 0.14% solution. 
Sethoxydim is not a volatile compound so inhalation exposure during and 
after application would be negligible. Dermal exposure would be minimal 
in light of the protective clothing and the low application rate. 
According to BASF post-treatment (re-entry) exposure would be 
negligible for these use sites as contact with treated surfaces would 
be low. BASF concludes that the potential for non-occupational exposure 
to the general population is insignificant.

D. Cumulative Effects

    BASF also considered the potential for cumulative effects of 
sethoxydim and other substances that have a common mechanism of 
toxicity. BASF is aware of one other active ingredient which is 
structurally similar, clethodim. However, BASF believes that 
consideration of a common mechanism of toxicity is not appropriate at 
this time. BASF does not have any reliable information to indicate that 
toxic effects produced by sethoxydim would be cumulative with clethodim 
or any other

[[Page 71924]]

chemical; thus BASF is considering only the potential risks of 
sethoxydim in its exposure assessment.

E. Safety Determination

    1. U.S. population-- Reference dose (RfD). Using the conservative 
exposure assumptions described above, BASF has estimated that aggregate 
exposure to sethoxydim will utilize 44% of the RfD for the U.S. 
population. EPA generally has no concern for exposures below 100% of 
the RfD. Therefore, based on the completeness and reliability of the 
toxicity data, and the conservative exposure assessment, BASF concludes 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to residues of sethoxydim, including all anticipated 
dietary exposure and all other non-occupational exposures.
    2. Infants and children--i. Developmental toxicity. Developmental 
toxicity was observed in a developmental toxicity study using rats but 
was not seen in a developmental toxicity study using rabbits. In the 
developmental toxicity study in rats a maternal NOAEL of 180 mg/kg/day 
and a maternal LOAEL of 650 mg/kg/day (irregular gait, decreased 
activity, excessive salivation, and anogenital staining) was 
determined. A developmental NOAEL of 180 mg/kg/day and a developmental 
LOAEL of 650 mg/kg/day (21 to 22% decrease in fetal weights, 
filamentous tail and lack of tail due to the absence of sacral and/or 
caudal vertebrae, and delayed ossification in the hyoids, vertebral 
centrum and/or transverse processes, sternebrae and/or metatarsals, and 
pubes). Since developmental effects were observed only at doses where 
maternal toxicity was noted, BASF concludes that the developmental 
effects observed are believed to be secondary effects resulting from 
maternal stress.
    ii. Reproductive toxicity. A 2-generation reproduction study with 
rats fed diets containing 0,150, 600, and 3,000 ppm (approximately 0, 
7.5, 30, and 150 mg/kg/day) produced no reproductive effects during the 
course of the study. Although the dose levels were insufficient to 
elicit a toxic response, the Agency has considered this study usable 
for regulatory purposes and has established a free-standing NOAEL of 
3,000 ppm (approximately 150 mg/kg/day) Proposed Rule at 60 FR 13941.
    iii. Reference dose. Based on the demonstrated lack of significant 
developmental or reproductive toxicity BASF believes that the RfD used 
to assess safety to children should be the same as that for the general 
population, 0.09 mg/kg/day. Using the conservative exposure assumptions 
described above, BASF has concluded that the most sensitive child 
population is that of children ages 1-6. BASF calculates the exposure 
to this group to be approximately 95% of the RfD for all uses 
(including those proposed in this document). Based on the completeness 
and reliability of the toxicity data and the conservative exposure 
assessment, BASF concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
residues of sethoxydim, including all anticipated dietary exposure and 
all other non-occupational exposures.

F. International Tolerances

    A maximum residue level has not been established for sethoxydim on 
aspargus, carrot, cranberry, peppermint, spearmint or horseradish by 
the Codex Alimentarius Commission.
[FR Doc. 98-34291 Filed 12-29-98; 8:45 am]
BILLING CODE 6560-50-F